BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT-I POSITIONER

    MDR report key: 12409592 · Received September 1, 2021

    Report

    Report Number
    2242352-2021-00716
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    August 4, 2021
    Report Date
    September 23, 2021
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    MWS
    UDI-DI
    00607567700574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED SECTION: H-3 DEVICE NOT EVAL PROVIDE CODE: FROM "OTHER" TO "DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN." TRACKWISE ID # (B)(4).

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). UPDATED SECTIONS: G4, G7, H2, H3, H6, H10. ANALYSIS OF PRODUCTION: (3331/213/67) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE MANUFACTURING PROCESS AND THE REPORTED FAILURE. HISTORICAL DATA ANALYSIS: (4109/213/67) THE REVIEW OF THE HISTORICAL DATA INDICATES THAT NO OTHER SIMILAR COMPLAINTS WAS REPORTED FOR THE SAME LOT NUMBER AND REPORTED FAILURE MODE. TREND ANALYSIS: (4110/213/67) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD SEPT-2019 THROUGH AUG-2021 WAS REVIEWED. THERE WERE NO TRIGGERS IDENTIFIED FOR THE REVIEW PERIOD. COMMUNICATION/INTERVIEWS: (4111/213/67) COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION. TESTING OF ACTUAL/SUSPECTED DEVICE: (10/13/4315) THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 08/19/2021. PHOTOGRAPHS WERE PROVIDED BY THE ACCOUNT. A PHOTOGRAPHIC INSPECTION WAS CONDUCTED THE PACKAGING BOX WAS OBSERVED IN THE PHOTOGRAPHS. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE PACKAGING BOX OTHER THAN THE NORMAL WEAR AND TEAR FROM SHIPPING. THE PRODUCT BOX WAS ALSO OBSERVED IN THE PHOTOGRAPH. THERE WAS A DENT ON THE BOX CLOSEST TO THE PRODUCT NAME PRINTED ON THE BOX. AN INVESTIGATION WAS CONDUCTED ON 09/08/2021. A VISUAL INSPECTION WAS CONDUCTED. NO SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THE PRODUCT BOX WAS OBSERVED TO BE INTACT AND NOT OPENED. AN INDENT ON THE BOX WAS OBSERVED ON THE ON THE FRONT OF THE PRODUCT BOX. THERE WERE NO OTHER VISUAL DEFECTS OBSERVED. BASED ON THE RETURNED CONDITION OF THE DEVICE, THE REPORTED FAILURE ¿MANUFACTURING, PACKAGING OR SHIPPING PROBLEM" WAS CONFIRMED. THE DHR, SHOP FLOOR PAPERWORK WAS REVIEWED. THE VENDOR CERTIFIES THAT THIS DEVICE SERIAL/LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 0

    GETINGE GROUP TAIWAN CO., LTD. REPORTED THAT DURING RECEIPT OF A SHIPMENT (ACROBAT-I POSITIONER), THEY RECEIVED THIS SHIPMENT AND THE OUTSIDE BOX WAS IN FINE CONDITION. BUT THEY FOUND ONE BOX WITH A HOLE AND CUSTOMER WON¿T ACCEPT THEM. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    TRACKWISE ID # (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    GETINGE GROUP (B)(6) CO., LTD. REPORTED THAT DURING RECEIPT OF A SHIPMENT (ACROBAT-I POSITIONER), THEY RECEIVED THIS SHIPMENT AND THE OUTSIDE BOX WAS IN FINE CONDITION. BUT THEY FOUND ONE BOX WITH A HOLE AND CUSTOMER WON¿T ACCEPT THEM. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301941 ACROBAT-I POSITIONER STABILIZER, HEART MWS MAQUET CARDIOVASCULAR LLC ACROBAT-I POSITIONER 25152928 00607567700574

    Patients

    Seq Age Sex Outcome Treatment
    1